EXHIBIT 10.162
CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS OF THIS
DOCUMENT HAVE BEEN REDACTED AND
HAVE BEEN FILED SEPARATELY
WITH THE U.S. SECURITIES AND
EXCHANGE COMMISSION
Execution Copy
API SUPPLY
AGREEMENT
This API Supply Agreement (this
“Agreement”) is made as of this 22
nd
day of November, 2006
(“Effective Date”), by and between INDEVUS
PHARMACEUTICALS INC., a corporation organized and existing
under the laws of the State of Delaware, United States of America,
and having an office at 33 Hayden Avenue, Lexington, MA 02421-7971
, United States (“Indevus”) and HELSINN
CHEMICALS SA and HELSINN ADVANCED SYNTHESIS SA , both
corporations organized and existing under the law of Switzerland
and having their registered office at Via Industria 24, 6710
Biasca, Switzerland (“Helsinn”). Indevus and Helsinn
hereinafter are collectively referred to as the
“Parties” and individually as a
“Party”.
WHEREAS, Indevus holds certain
rights to manufacture, market and sell pharmaceutical products
containing the API (as defined below);
WHEREAS, Indevus wishes to purchase
from Helsinn API In Bulk (as defined below) for subsequent
formulation, tabletting, packaging, and commercial sale by Indevus
or Indevus’ designee and for certain clinical and other
purposes; and
WHEREAS, Helsinn has suitable
facilities and equipment and sufficient qualified personnel to
manufacture API In Bulk, and is willing to provide such API supply
on the terms and conditions set forth below.
NOW, THEREFORE, the Parties hereto,
intending to be legally bound, agree as follows:
As used in this
Agreement:
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1.1
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“
Act ” means the United States Food, Drug, and Cosmetic
Act of 1938, as amended, and the rules and regulations promulgated
thereunder, or any successor act, as the same shall be in effect
from time to time.
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1.2
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“
Active Pharmaceutical Ingredient ” or “
API ” means the compound [*] which is more commonly
known as TROSPIUM CHLORIDE, described in and conforming to the
Specifications.
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1.3
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“
Adverse Experience ” or “ AE ”
means any unfavorable and unintended change in the structure,
function, or chemistry of the body temporally associated with any
use of a product or of a derivative thereof containing API, whether
or not the adverse experience is considered to be related to the
use of such product, including but not limited to any of the
following: an unexpected side effect, injury, toxicity or
sensitivity reaction, which may include an experience of unexpected
incidence and severity; an adverse
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[*]
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CONFIDENTIAL
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experience occurring in the course
of the use of a drug product in professional practice; an adverse
experience occurring in clinical studies; an adverse experience
occurring from drug overdose, whether accidental or intentional; an
adverse experience occurring from drug abuse; an adverse experience
occurring from drug withdrawal; and any significant failure of
expected pharmacological action; but in any event shall mean
adverse drug experiences, as defined by 21 CFR
Section 314.80.
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1.4
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“
Affiliate ” means with respect to a Party, any
corporation or other business entity which, directly or indirectly,
is controlled by, controls, or is under common control with such
Party. For this purpose, “control” shall be deemed to
mean direct or indirect ownership of fifty percent (50%) or
more of the stock or other equity of such entity.
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1.5
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“
Batch ” means a specific quantity of API that is
produced according to a single manufacturing order during the same
cycle of manufacture.
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1.6
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“
Business Day ” shall mean any day that is not a
Saturday, a Sunday, a day on which the New York Stock Exchange is
closed, or other day on which banks are required or authorized by
law to be closed in Biasca, Switzerland.
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1.7
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“
CFR ” means the United States Code of Federal
Regulations.
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1.8
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“
Commercially Reasonable Efforts ” means, with respect
to a Party, the efforts and resources which would be used
(including without limitation the promptness in which such efforts
and resources would be applied) by such Party, consistent with
generally-accepted industry standards for a company of comparable
size and business in the industry, with regard to the diligent
manufacture and commercialization of pharmaceutical products of
similar market and profit potential at a similar stage in
development or product life. The term “Commercially
Reasonable” shall have a corresponding meaning.
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1.9
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“
Confidential Information ” means all information,
data, know-how and all other business, technical and financial data
disclosed hereunder by one Party or any of its Affiliates to the
other Party or any of its Affiliates, except any portion thereof
which:
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(a)
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at the time of
disclosure, is public knowledge;
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(b)
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after
disclosure, becomes public knowledge by publication or otherwise,
except by breach of this Agreement by the recipient;
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(c)
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the recipient
can demonstrate by its written records was in the recipient’s
possession at the time of such disclosure, and which was not
acquired, directly or indirectly, from the disclosing Party or its
Affiliates;
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(d)
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is lawfully
disclosed to the recipient on a non-confidential basis by a third
party who is not obligated to the disclosing Party or any other
third party to retain such Confidential Information in
confidence;
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(e)
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results from
research and development by the recipient independent of such
disclosure as shown by competent evidence; or
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2
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(f)
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is required to
be disclosed by legal process; provided, in each case the Party so
disclosing information timely informs the other Party and uses its
reasonable efforts to limit the disclosure and maintain
confidentiality to the extent possible and, if possible, permits
the other Party to attempt by appropriate legal means to limit such
disclosure, subject to the provisions of
Section 4.6.
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All information exchanged pursuant
to this Agreement shall be considered Confidential Information.
Confidential Information disclosed orally, visually and/or in
another intangible form shall be identified by the disclosing Party
to the receiving Party as confidential at the time of such
disclosure and confirmed in writing to the receiving party within
thirty (30) days after such disclosure.
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1.10
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“
Current Good Manufacturing Practices ” or the letters
“ GMP ” or “ cGMP ” means
current good manufacturing practice and standards as provided for
(and as amended from time to time) in European Community Directive
91/356/EEC (Principles and guidelines of good manufacturing
practice for medicinal products for human use) and in the Current
Good Manufacturing Practice Regulations of the U.S. Code of Federal
Regulations Title 21 (21 C.F.R. Parts 210 and 211) in relation to
the production of pharmaceutical intermediates and active
pharmaceutical ingredients, and applicable ICH Harmonised
Tripartite Guideline Q7a, Good Manufacturing Practice Guide for
Active Pharmaceutical Ingredients, and subject to any arrangements,
additions or clarifications agreed in writing from time to time
between the Parties in the Quality Technical Agreement.
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1.11
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“
DMF ” means a Drug Master File as defined in 21 C.F.R.
§314.420 in the United States, including all supplements and
amendments thereto or any foreign counterpart of a U.S.
DMF.
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1.12
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“
FDA ” means the United States Food and Drug
Administration and any successor agency having substantially the
same functions.
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1.13
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“
Finished Product ” means any drug product containing
or comprising API, in its finished, labeled and packaged form,
ready for sale to the market, including all samples
thereof.
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1.14
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“
HCI” means [*], an Affiliate of Helsinn.
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1.15
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“
Helsinn Facility(ies) ” means any Helsinn or HCI
manufacturing facility(ies) that is qualified or approved in the
NDA to manufacture API and that is used for the manufacture of API
pursuant to this Agreement.
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1.16
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“
Helsinn Payment ” means [*].
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1.17
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“ In
Bulk ” means quantities of API formulated and packaged in
non-retail size containers.
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1.18
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“
Launch Period ” means the period commencing on the
launch date of SANCTURA XR ™ in the United States and expiring on
(a) December 31 of the calendar year in which such launch
date occurs if the launch date occurs in the first three months
of
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[*]
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TREATMENT REQUESTED
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3
such year; or
(b) December 31 of the calendar year immediately
following the calendar year in which the launch date occurs if the
launch date occurs after the first three months of such
year.
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1.19
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“
Losses ” means any and all damages, awards,
deficiencies, settlement amounts, defaults, assessments, fines,
dues, penalties (including penalties imposed by any governmental
authority), costs, fees, liabilities, obligations, taxes, liens,
losses, and expenses (including without limitation court costs,
interest and reasonable fees of attorneys, accountants and other
experts) awarded or otherwise paid or payable to third
parties.
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1.20
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“
NDA ” means a New Drug Application pursuant to
Section 505 of the Act submitted to the FDA or any successor
application or procedure or any foreign counterpart of a U.S. New
Drug Application for approval to market, including, where
applicable, applications for pricing and reimbursement
approval.
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1.21
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“
Purchase Price ” shall have the meaning set forth in
Section 6.3 hereof.
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1.22
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“
Quality Technical Agreement ” means the quality
assurance/quality control agreement to be entered into by Indevus
and Helsinn in accordance with Schedule 1.22 and as
contemplated by Section 3.7 and to be appended to this
Agreement as Exhibit 1.22.
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1.23
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“
Regulatory Authority ” means (i) the FDA and/or
(ii) any regulatory body with similar regulatory authority in
any other jurisdiction anywhere in the Territory.
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1.24
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“
Regulatory Standards ” means (i) obtaining and
maintaining any and all permits, licenses, filings and
certifications required by the FDA or other Regulatory Authorities,
and compliance with cGMPs, applicable to the Helsinn Facilities or
Helsinn’s activities hereunder, and (ii) any laws,
rules, regulations and standards of any Regulatory Authority,
whether within or outside the United States that apply to such
activities.
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1.25
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“
SANCTURA XR ™ ” means the once-daily formulation of
SANCTURA ® currently under development by
Indevus.
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1.26
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“
Specifications ” means the quality assurance and
quality release specifications for API as set forth on Schedule
1.26, subject to such modifications to the Specifications
agreed between Indevus and Helsinn in writing and set forth in an
amendment to this Agreement as a restated Schedule 1.26
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1.27
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“
Territory ” means worldwide.
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Where words and phrases are used
herein in the singular, such usage is intended to include the
plural forms where appropriate to the context, and vice versa. The
words “ including ”, “ includes
” and “ such as ” are used in their
non-limiting sense and have the same meaning as “including
without limitation” and “including but not limited
to”. References to Articles, Sections, subsections, and
clauses are to the same with all their subparts as they appear in
this Agreement.
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2.1
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Purchase and
Sale . Subject to the
terms and conditions of this Agreement, (a) Indevus hereby
agrees to purchase from Helsinn an [*] per year of API for each
rolling [*] period of the Initial Term commencing after the [*] and
expiring after Indevus has purchased from Helsinn [*] of API (the
“Minimum Purchase Requirement”), and (b) Helsinn
agrees to manufacture and supply API exclusively to Indevus and/or
Indevus’ designee, pursuant to purchase orders placed by
Indevus from time to time, for all purposes, including without
limitation, subsequent formulation, encapsulating, tabletting,
packaging and commercial sale by Indevus and/or Indevus’
designees and for certain clinical and other purposes in the
Territory. Helsinn shall supply the API in appropriate bulk
containers. Subject to the last sentence of this Section 2.1,
in the event that for any calendar year commencing on the [*] of
the [*] of the[*], Indevus does not satisfy the Minimum Purchase
Requirement, Indevus shall pay Helsinn the Helsinn Payment on the
number of batches required to meet the Minimum Purchase Requirement
for such year that were not purchased. For example, if during the
calendar year commencing on the [*] anniversary of the [*] of
the[*] (the [*] Contract Year”), Indevus purchases [*], but
during the prior calendar year Indevus had purchased at least [*],
Indevus will have satisfied the Minimum Purchase Requirement for
the [*] Contract Year and no Helsinn Payment would be due for the
[*] Contract Year. If however, for the prior calendar year Indevus
had purchased [*], Indevus would not have satisfied the Minimum
Purchase Requirement for the [*] Contract Year and a Helsinn
Payment for [*] would be due for the [*] Contract Year. In the
event that before the end of any calendar year commencing on the
[*] anniversary of the [*] of the [*], Indevus notifies Helsinn of
its inability to purchase, by the end of each rolling two year
period, the number of batches required to meet in aggregate the
Minimum Purchase Requirement for the applicable period, Indevus
shall pay Helsinn [*] percent ([*]%) of the Helsinn Payment on the
number of batches required to meet the Minimum Purchase Requirement
that are not purchased by Indevus in the next calendar year if
Helsinn [*] said Helsinn Payment [*]
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2.2
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Cooperation . Indevus and Helsinn will cooperate with each
other as may be necessary and customary in consideration of
industry practice, and will disclose all material information
necessary to enable each other to perform their duties under this
Agreement in a timely fashion.
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2.3
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Specific
Duties . In addition to
its general obligations relating to the manufacture and supply of
API, Helsinn shall be responsible for performing the following
services at Helsinn’s cost:
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(a)
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quality control
and testing of all API in order to monitor compliance with all
applicable Regulatory Standards, the Specifications and this
Agreement;
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(b)
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conducting
stability testing of API in accordance with the procedures set
forth in the Quality Technical Agreement;
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(c)
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summarizing
implemented changes and supplying latest versions of approved
critical documentation, and providing other information necessary
for Indevus to prepare, submit, obtain and maintain all regulatory
filings relating to the manufacture of the API under the terms of
this Agreement; and
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(d)
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performing such
other services as agreed upon in writing by the Parties.
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[*]
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CONFIDENTIAL
TREATMENT REQUESTED
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5
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III.
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API QUANTITY,
QUALITY AND MANUFACTURING PROCESSES; TECHNICAL
ASSISTANCE
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3.1
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Quantity . Subject to the terms and conditions of this
Agreement, Helsinn will manufacture and supply to Indevus or
Indevus’ designee quantities of API ordered by Indevus or
Indevus’ designee. Helsinn agrees to reserve capacity for the
quantities of API as defined in Schedule 3.1 . Helsinn shall
have no obligation to supply quantities in excess of those set
forth in Schedule 3.1 , but shall use its Commercially
Reasonable Efforts to accommodate Indevus demand for excess
quantities.
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3.2
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Quality . All API manufactured and sold by Helsinn to
Indevus under this Agreement will meet the Specifications, as well
as the quality assurance standards established in the Quality
Technical Agreement. Such Specifications, as well as the terms and
conditions of the Quality Technical Agreement, are subject to
modification from time to time by mutual written agreement of the
Parties. Subject to the terms of this Section 3.2 and
Section 6.3, prior to implementation of any such changes to
the Specifications, the Parties agree to negotiate in good faith in
an attempt to reach agreement on (a) the new Purchase Price
for any API manufactured and supplied hereunder by Helsinn which
embodies such changes, based solely on the effect of such changes
on Helsinn’s manufacturing costs for the API (including, if
applicable, any decrease in the Purchase Price in the event of any
decrease in the costs of starting and raw materials used in the
manufacture of the API) and (b) any other amendments to this
Agreement which may be necessitated by such changes ( e.g. ,
an adjustment to the lead time for purchase orders).
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(a)
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Except as set
forth in sub-section 3.3 (b), for changes, including, but not
limited to process changes, site changes and supplier changes
intended to improve operational efficiency, effectiveness and
risk-management (the “Improvements”), both Parties
shall agree in writing whether to implement such Improvement or
not. If the Parties agree to implement such Improvement, the
Parties shall also agree in writing on an Improvement program
including an assessment of the costs of implementation of the
program and of the expected financial impact of the Improvement.
Upon completion of the Improvement program, should the Improvement
have been demonstrated to be feasible, the Parties shall agree in
writing which Party will be responsible to pay documented costs and
expenses for the implementation of said Improvement, being
understood that should Indevus be responsible for all such costs
and expenses the Purchase Price will be reduced by an amount equal
to [*]% of the amount of the decrease, if any, in the costs of
starting and raw materials due to the implementation of the
Improvement, while should Helsinn be responsible for all such costs
and expenses the Purchase Price will be reduced by an amount equal
to [*]% of the amount of the decrease, if any, in the costs of
starting and raw materials.
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(b)
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The Parties
acknowledge that (i) [*], and (ii) [*]/kg (the
“[*]”). Helsinn agrees to use its best efforts to [*]
and to [*]. The Purchase Prices set forth on Part B of Schedule
6.3 shall be effective [*]; provided, however, that in the
event that the actual [*], the Purchase Prices set forth on Part B
of Schedule 6.3 [*]. For example, if the [*] is [*], the Purchase
Price set forth on Part B of Schedule 6.3 [*]
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[*]
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CONFIDENTIAL
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6
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3.4
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Manufacturing Processes . Helsinn has furnished and will continue to
furnish to Indevus during the term of this Agreement a copy of its
current production procedures and in the Quality Technical
Agreement the Parties will agree upon the equipment to be used to
produce the API. Except as otherwise set forth in this Agreement,
costs incurred by Helsinn as a result of any such changes or
modifications requested by the FDA or by Indevus and relating
solely to the production of the API will be borne by Indevus; costs
for other changes affecting Helsinn’s compliance with cGMP or
affecting other products generally will be borne by
Helsinn.
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3.5
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Documentation . Indevus shall provide Helsinn with initial
methods and Specifications for manufacturing the API as set forth
in the attached Schedule 1.26. Indevus shall also promptly
provide Helsinn with all available safety data and information
concerning the API, process and related materials, including
without limitation all material safety data sheets
(“MSDS’s”).
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3.6
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Communication . Helsinn and Indevus will respond to requests
for support, information and approvals within ten
(10) Business Days. If a complete response is not possible
within such ten (10)-day period, the Party owing the response shall
communicate within such ten (10)-day period the reason for the
delay and when the response will be available.
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3.7
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Quality
Technical Agreement .
Within sixty (60) days after the Effective Date, the Parties
shall enter into a Quality Technical Agreement outlining
responsibilities and key contacts for API quality and compliance
related issues. Helsinn will provide Indevus with certain
production and control information for review prior to release as
specified in the Quality Technical Agreement. The Quality Technical
Agreement will also address, without limitation, annual product
reviews, returned goods, regulatory audits, compliance with Current
Good Manufacturing Practices, and such other quality related
concerns deemed appropriate. The final agreed Quality Technical
Agreement will be attached to this Agreement as Exhibit 1.22
and deemed a part of this Agreement. In the event that the Quality
Technical Agreement contains material provisions that substantially
differ from applicable comparable Regulatory Standards, the
Regulatory Standards shall control.
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IV.
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CONFIDENTIAL
INFORMATION
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4.1
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The Parties
acknowledge that they have provided Confidential Information to
each other in connection with the manufacture and supply of the
API, and further acknowledge that all such Confidential Information
(as well as any additional Confidential Information provided by one
Party to the other hereunder) shall be subject to the provisions of
this Section IV. Any and all confidential information, knowledge,
technology and trade secrets relating to the API and provided by
Indevus and/or Helsinn to the other shall be deemed Confidential
Information.
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4.2
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During the term
of this Agreement and for ten (10) years thereafter, all
Confidential Information disclosed and confirmed in writing and
designated as confidential by the disclosing party within thirty
(30) days from oral disclosure, including confidential
information so designated that was disclosed by either Party prior
to the Effective Date, shall be held in confidence by the receiving
party, shall not be used by the receiving party for any purpose
except as provided hereunder and
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[*]
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7
shall not be disclosed to third
parties except for disclosure to its Affiliates or governmental
authorities, in connection with pre-clinical or clinical
development activities or the manufacturing of Finished Product, or
except as otherwise necessary to carry out the receiving
party’s obligations under this Agreement. If a receiving
party finds it necessary to disclose such Confidential Information
to a third party, the receiving party will not do so without first
obtaining the written consent of the disclosing party (which shall
not be unreasonably withheld) and entering into an agreement with
the third party which binds the third party to obligations of
restricted use and disclosure no less stringent than those
undertaken by the Parties in this Agreement.
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4.3
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Neither Party
shall distribute any Confidential Information of the other except
to its employees, agents or consultants who have a need to know
exclusively in connection with the performance of their duties in
satisfying the obligations of such Party hereunder. Any employee,
agent or consultant who receives Confidential Information shall be
advised as to the confidential nature thereof and the prohibitions
contained herein. All copies of any portions of any Confidential
Information distributed as provided in this Section will be
identified as confidential. Upon termination of this Agreement, and
upon the request of the disclosing party, the receiving party shall
return or destroy all such Confidential Information and any copies
thereof in its possession, except that each Party may retain one
copy of Confidential Information solely for archival
purposes.
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4.4
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Termination of
this Agreement shall not operate to extinguish either Party’s
obligation to treat Confidential Information as provided herein,
and the same shall continue in effect in accordance with this
Section.
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4.5
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Nothing
contained herein shall be deemed to grant to either Party, either
expressed or implied, a license or other right or interest in the
Confidential Information of the other or in any patent, trademark
or other similar property of the other.
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4.6
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Neither Party
shall use the name of the other, nor disclose the existence of this
Agreement for any purpose, without the prior written consent of the
other, which shall not be unreasonably withheld or delayed
provided, however, it is understood that Indevus may make
disclosure of this Agreement and the terms hereof, in any filings
required by the United States Securities and Exchange Commission
(“SEC”) and may file this Agreement as an exhibit to
any filing with the SEC. In connection with any such filing,
Indevus shall endeavor to obtain confidential treatment of economic
and trade secret information and shall deliver to Helsinn in
advance of any filing a redacted copy of this Agreement to enable
Helsinn to give comments and suggestions on economic and trade
secret information to be kept confidential.
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(a)
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Not later than
[*] prior to the estimated launch date of SANCTURA XR
™ [*], Indevus shall provide Helsinn with a
forecast of its estimated requirements for API for the period [*]
calendar quarters from the estimated launch date, broken down on a
quarterly basis. Within [*] prior to the estimated launch date
of
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SANCTURA XR ™ , Indevus shall provide Helsinn with an updated
forecast of its estimated requirements of API for the [*] calendar
quarters commencing after [*] after the launch date, broken down on
a quarterly basis. Within [*] days after the launch date, and
thereafter on a quarterly basis during the term of this Agreement,
Indevus shall provide Helsinn with a rolling forecast of its
estimated requirements of API, broken down on a quarterly basis,
for [*] consecutive calendar quarters (commencing at the beginning
of the [*] complete calendar quarter that commences after the date
of such forecast).
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(b)
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The first [*]
calendar quarters of each forecast provided after the launch date
of SANCTURA XR ™ (the “Binding Portion”) shall
represent a binding forecast and the remaining [*] calendar
quarters of each forecast shall be non-binding and shall represent
Indevus’s reasonable estimates only. Except as set forth in
the preceding sentence and the first sentence of Section 5.2,
all forecasts made hereunder shall be made to assist Helsinn in
planning its production and shall not be binding purchase orders,
and shall be without prejudice to Indevus’s subsequent
purchase orders for the API in accordance with the terms of this
Agreement. Each forecast provided by Indevus shall supersede any
previous forecast and may be expressed in a reasonable
range.
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5.2
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Purchase
Orders . Subject to the
terms and conditions of this Agreement, Indevus shall be bound to
order [*]percent ([*]%) of the forecasted quantities of API that
are subject to a Binding Portion of the most recent rolling
forecast referred to in Section 5.1. Indevus agrees to
purchase API in not less than full lot quantities, which as of the
Effective Date are approximately [*] kg ([*] kilograms) per batch.
Indevus or its designee shall provide Helsinn with purchase orders
on the standard purchase order forms of Indevus or its designee of
its requirements for API at least [*] days before it requires each
delivery of API, specifying the required delivery date in each
purchase order. Provided Indevus’s purchase orders do not
exceed Helsinn’s reserve capacity set forth in Schedule
3.1 , Helsinn shall accept all Indevus purchase orders and
shall supply Indevus in accordance with them, provided, however,
that in case of any conflict or inconsistency between the terms of
said orders and the terms and conditions of this Agreement, the
terms of this Agreement shall prevail. Indevus can increase or
decrease its firm order quantities with Helsinn’s prior
agreement and Helsinn can adjust its shipping quantities with
Indevus’s prior agreement. Both parties shall use their
Commercially Reasonable Efforts to accommodate reasonable change
requests from the other. Helsinn shall use Commercially Reasonable
Efforts to prevent an interruption of supply to Indevus and to
execute all orders received and accepted pursuant to Article V
within [*] days from the date of receipt and acceptance of the
relevant order by Helsinn.
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5.3
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Shortages . Helsinn shall acknowledge and provide Indevus,
subject to Section 5.2 above, with a written acceptance of
each purchase order within five (5) Business Days following
Helsinn’s receipt thereof, provided, that Helsinn shall
immediately notify Indevus of any problems or unusual production
situations which may adversely affect production or quality of API
or its timely delivery to Indevus or its designee. In addition, if,
at any time Helsinn becomes aware or anticipates that it will not
be able to satisfy Indevus’s forecasts or ordered
requirements for API, in whole or in part, due to any reason then
Helsinn shall: (i) give Indevus notice thereof within five
(5) Business Days of receipt of a particular forecast or
purchase order (or upon Helsinn’s
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[*]
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CONFIDENTIAL
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9
reasonable belief that it cannot
fulfill the forecast or purchase order if such date is after such
five (5) Business Day period), (ii) if such inability is
partial, fulfill purchase orders with such quantities of API as are
available and supply the remaining quantities of API through HCI on
a timely basis and (iii) if such inability is total, fulfill
purchase orders of API through HCI, provided that all API
manufactured and supplied by HCI is in accordance with the
Specifications, applicable Regulatory Standards, and the terms and
conditions of this Agreement and the Quality Technical Agreement.
In addition, in the event neither Helsinn nor HCI can fulfill such
purchase orders in accordance with such requirements, Helsinn shall
take all Commercially Reasonable steps including as set forth under
Section 5.4, to enable Indevus to procure adequate quantities
of API from a second source. In the event of any failure to supply
by Helsinn, Indevus shall be relieved from its obligations under
this Agreement to purchase any quantities of API identified in any
Binding Portion of a forecast or outstanding purchase orders and of
the Minimum Purchase Requirements. Nothing in this
Section 5.3, Section 5.4 or Section 7.7, shall limit
any contractual rights or remedies that may be available to Indevus
on account of any failure to supply API pursuant to the terms of
this Agreement.
At the request of Indevus, Helsinn
shall take all Commercially Reasonable steps to procure all
necessary licenses, permits, certifications and approvals relating
to the qualification of HCI and/or another Helsinn Facility as a
second manufacturer of API, and to comply and cause HCI or such
other Helsinn Facility, as applicable, to comply with such other
requirements, obligations and responsibilities as are necessary to
fully enable HCI or such other Helsinn Facility, as applicable to
undertake the manufacturing and supply of API in accordance with
the Specifications, applicable Regulatory Standards, and the terms
and conditions of this Agreement and the Quality Technical
Agreement. Such alternative production site and all related costs
and expenses shall be approved by Indevus before commencement of
routine production and all actions required to have a DMF for API
approved by the FDA will be put in place and agreed between both
Parties. Costs and expenses related to obtainment and maintenance
of the above mentioned licenses, permits, certifications and
approvals shall be borne by Indevus, provided, however, that
Helsinn shall bear or reimburse Indevus for all such costs and
expenses incurred in the event or as a result of Helsinn’s
inability to supply or fulfill its requirements under this
Agreement.
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5.5
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API
Inventory . Indevus may
use any API produced by Helsinn and delivered prior to the date of
this Agreement, including validation batches of API (“API
Inventory”), as launch stocks and/or to satisfy
Indevus’s requirements to order any API quantities subject to
any Binding Portion of a forecast or purchase order requirements
provided under this Agreement including the Minimum Purchase
Requirements, subject to compliance with applicable laws and other
provisions of this Agreement. In such event, the quantities of API
Inventory used to satisfy the Binding Portion of a forecast or
purchase order requirement shall be offset against the requirements
to purchase the comparable quantities of API subject to any such
Binding Portion of a forecast or purchase order
requirement.
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10
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VI.
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PRICE, SHIPMENT
AND PAYMENT
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6.1
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Helsinn’s Responsibilities
. Helsinn will properly manufacture
the API so that it may be lawfully and safely shipped to Indevus or
its designee worldwide. Helsinn will prepare and execute all
reasonably necessary shipping documents, consisting of Packing
List, Dangerous Goods Declaration, MSDS, Certificate of Analysis
and Certificate of GMP compliance. Indevus will choose the carrier
and the designee by indicating both on its purchase order provided
to Helsinn.
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6.2
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Terms of
Shipment . Upon receipt
from Indevus of an authorization for release as set forth in
Section 7.1, Helsinn will invoice API [*] (Incoterms 2000).
Transportation to final destination will be carried out at the care
of Helsinn, according to Indevus’s written instructions, by
common carrier designated by Indevus. If Indevus does not designate
a common carrier, Helsinn may select the common carrier. Risk of
loss shall pass from Helsinn to Indevus [*]. All transport and
insurance costs will be borne by [*]. All API to be delivered
pursuant to this Agreement shall be delivered in accordance with
this Section 6.2, suitably packed in bulk containers for
shipment, and marked for shipment to the final destination point
indicated in Indevus’ purchase order. The shipping packaging
used in connection with API deliveries shall be in accordance with
cGMP with respect to protection of the API during transportation,
taking into consideration the mode(s) of transport Indevus has
elected to use for each such shipment, the final destination point
of each such shipment and reasonable expectations regarding
shipment time duration and possible delays associated
therewith.
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6.3
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Price . Helsinn shall invoice Indevus the Purchase
Price for all API delivered as set forth in Schedule
6.
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